PREMIER VALUE ALLERGY- diphenhydramine hydrochloride cream

PREMIER VALUE ALLERGY by

Drug Labeling and Warnings

PREMIER VALUE ALLERGY by is a Otc medication manufactured, distributed, or labeled by TAI GUK PHARM. CO., LTD., UNITED EXCHANGE CORP.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredients                                                                            Purpose

Diphenhydramine Hydrochloride USP, 2% .........................................Topical analgesic

Zinc acetate, 0.1% .........................................................................Skin Protectant

PURPOSE

Uses

Temporarily relieves pain and itching associated with: insect bites, minor burns, sunburn, minor skin irritations, minor cuts, scrapes, rashes due to poison ivy, poison oak, and poison sumac. Dries the oozing and weeping of poison ivy, poison oak, and poison sumac.

WARNINGS

Warnings

For external use only

DO NOT USE

Do not use on large area of the body or with any other product containing diphenhydramine, even one taken by mouth.

ASK DOCTOR

Ask a doctor before use

on chicken pox or on measles.

WHEN USING

When using this product

avoid contact with the eyes.

STOP USE

Stop use and ask a doctor if condition worsens or does not improve within 7 days, or symptoms persist for more than 7 days, or clear up and occur again within a few days.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

INDICATIONS & USAGE

Directions

• do not use more than directed
• adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily, or as directed by a doctor
• children under 2 years of age: consult a doctor
• discontinue use and consult a physician if rash or irritation develops
  

STORAGE AND HANDLING

Other information

• store at 20o to 25oC (68o to 77oF)
• Lot No. and Exp. Date: see box or see crimp of tube
  

DOSAGE & ADMINISTRATION

Distributed By:

Chain Drug Consortium, LLC.

3301 N.W. Boca Raton Blvd., Suite 101

Boca Raton, FL 33431

INACTIVE INGREDIENT

Inactive ingredients

glycerin, sodium chloride, petrolatum, cetyl alcoho, dimethicone, isopropyl palmitate, distearyldimonium chloride, methylparaben, propylparaben, purified water, hydroxyethyl cellulose

PRINCIPAL DISPLAY PANEL

Enter section text here

INGREDIENTS AND APPEARANCE

PREMIER VALUE ALLERGY  
diphenhydramine hydrochloride cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68169-0127
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)	DIPHENHYDRAMINE HYDROCHLORIDE	2 g  in 100 g
ZINC ACETATE (UNII: FM5526K07A) (ZINC - UNII:J41CSQ7QDS)	ZINC ACETATE	0.1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM CHLORIDE (UNII: 451W47IQ8X)
PETROLATUM (UNII: 4T6H12BN9U)
CETYL ALCOHOL (UNII: 936JST6JCN)
DIMETHICONE (UNII: 92RU3N3Y1O)
ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)
DISTEARYLDIMONIUM CHLORIDE (UNII: OM9573ZX3X)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68169-0127-6	1 in 1 CARTON
1		28 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	09/17/2010

Labeler - TAI GUK PHARM. CO., LTD. (631101656)

Registrant - UNITED EXCHANGE CORP. (840130579)

Establishment
Name	Address	ID/FEI	Business Operations
TAI GUK PHARM. CO., LTD.		631101656	manufacture